Comparative Study of Patentability of Drug Polymorphism in Iran and the USA

Drug polymorphs are defined as a different arrangement of the same active compounds in crystalline form, which can potentially affect its therapeutic activity by changing the dissolution profile of drug upon administration. Discovery of new polymorphs therefore can provide added value for a previously marketed drug, due to the new advantages provided by the novel polymorph. Therefore, there is an extensive ongoing investigation to find and patent new polymorphs among pharmaceutical companies, which highlights the importance of secondary patenting regulations. In this article, the patenting regulations in the US regarding the secondary patenting are investigated. It is generally accepted that finding new polymorph possesses general requirements for intellectual property right registration. Two methods have been used for this study including library search and field investigation. Firstly the basic knowledge about polymorphism is noted and the views of supporters and opponents are discussed. Then the status of polymorph patenting in the Iranian and the US regulation are explained. Finally a few proposals are presented for regulatory bodies. Please cite this article as: Sadeghi M, Rafati F. Comparative Study of Patentability of Drug Polymorphism in Iran and the USA. Iran J Med Law 2020; 14(52): 117-136.